Field of Invention
This invention relates to a method of efficiently assessing the effectiveness of psychiatric medications as administered by physicians and more specifically to a methodology that compares the effectiveness of different medications across groups of patients based on changes in mental health scores using electronic systems. Additionally, the invention delineates when changes in medications are made during the course of medical visits for a single patient.
Description of Related Art
Regarding evaluating medication effectiveness for an individual patient, there are paper (e.g., Kopta, S. M., & Lowry, J. L., “Psychometric Evaluation of the Behavioral Health Questionnaire-20: A Brief Instrument for Assessing Global Mental Health and the Three Phases of Psychotherapy Outcome”, Psychotherapy Research, 12, 413-426, 2002) and electronic questionnaires (e.g., “Behavioral Health Measure-20 within the CelestHealth System-MH; within the OQ Analyst”) that assess mental health. Unfortunately, their use with medication treatments requires significant time and effort to associate questionnaire scores across medical visits with medication administration and changes in medication. For example, first, the patient is administered the paper-and-pencil questionnaire or an electronic questionnaire via computer. Second, the physician or staff must manually or electronically record the mental health score in the clinical notes or on a spread sheet and then record the type of medication administered. To detect changes in mental health over time, the notes must be reviewed date by date or the spread sheet visually scanned for changes in mental health scores. These changes would then have to be associated with the medication being administered at the time. This medication would also have to be entered into the notes or on the spreadsheet for the date of each visit.
There is no method available to systematically compare the effects of different medications across all patients in the physician's practice.
For years, pharmaceutical companies and universities have been comparing medication effectiveness using the research method of the randomized clinical trial (RCT). The typical RCT involves several steps (a) administering a psychiatric drug, a psychotherapy, or placebo pill to research subjects who are randomly assigned to two or more treatment conditions; (b) assessing the subjects' mental health at each medical visit using a questionnaire administered by paper or an electronic process (e.g., computer); (c) statistically analyzing the subjects' scores on the questionnaire; (d) based on these analyses, displaying the percent of subjects improved (i.e., percent of patients free of recurrence) across weeks for the medications being assessed in the RCT. This type of research provides information on medication effectiveness.
Software products are available that monitor across weeks the mental health of Individual subjects who are on a medication as prescribed in RCTs. These systems can also calculate the effectiveness of a single medication for groups of subjects. For example, Medical Outcome Systems, Inc. supports research studies and clinical trials by, among other things, providing graphs that display a mean mental health score on the ordinate with week number on the abscissa for a single subject and for all subjects participating in the RCT.
To understand the effectiveness of the medications that they administer, physicians rely on academic journals that publish the results of these RCTs. However, the RCT approach to evaluating medication effectiveness has been criticized along several lines. First, most RCTs are conducted by the pharmaceutical companies who sell the medications which are tested. These companies are not required to publish findings that are unfavorable to their product; therefore, there are concerns about the validity of the effectiveness claims made in many medication studies. Second, since most RCT subjects suffer from only one syndrome such as anxiety or depression, they do not represent the typical patient population seen by physicians in the real world. In contrast, the typical patient seen at the physician's office suffers from a combination of syndromes such as depression with panic attacks or depression with an eating disorder. These patients usually require a combination of drugs rather than just one medication. Additionally, practicing physicians do not have the time, staff, or statistical resources to assess in RCT fashion the effectiveness of medications that they actually prescribe to their patients.